Prashanth Gudla

Background

About Prashanth Gudla

• Competence with CDISC SDTM & ADAM Standards ICH-GCP SOP's 21CFR part-11 MedDRA WHO-DRUG CTC Common Toxicity Criteria (CTCAE) ICH guidelines and GCP requirements in new drug development and application process • Developed and validated safety and efficacy tables listings and figures for Summarizing clinical trial data according to the SAP (Statistical Analysis Plan) • Good Knowledge in CDISC SDTM and Implementation like creation of SDTM Mapping specification Annotations and metadata specifications like Define.xml for Submission to the regulatory bodies like FDA/EMEA/PMDA. • Extensive Knowledge in CDISC ADAM Standards Creating ADAM Specifications and Programming ADAM datasets like ADSL ADAE ADLB ADVS ADQS ADEX ADTTE etc to be submission/Analysis Ready. • Expertise in Building ADAM datasets including Complex efficacy datasets like ADRESP ADTTE and other datasets like ADEX ADQS as per the Analyses mentioned in SAP. • Good exposure in Developing and debugging SAS Macros that helps in re-usability of code and automating SAS programs. • Extensively used Do loops (Do Do While Do until etc) and Arrays for the Derivation of Complex Efficacy end points using the Clinical data date imputations EPOCH derivation. • Handled missing data and dropouts using Last Observation Carry Forward (LOCF) and Worst Observation Carry forward (WOCF) logics using LAG RETAIN concepts in SAS Data step programming. • Provide project/general training to new joiners/staff members mentor staff members to develop Standard process and technical assistance. • Validated SDTM & ADAM datasets using Pinnacle 21 validator and resolved the Issues Identified and Documented the unresolved issues in the SDTM/ADAM Reviewers Guide. • Worked in various therapeutic areas like Oncology Vaccines Alzheimer's Immunology CNS and Endocrinology Ophthalmology and Gastroenterology Etc. • Expertise in Mapping Tumor domains in Oncology Clinical Trials like TU TR and RS. And Good understanding of the RECIST Criteria and Derived many Primary and Secondary endpoints of Oncology trial like Overall Survival (OS) Progression Free Survival (PFS) Objective response rate (ORR) Best overall Response (BOR) Etc. • Efficiently Modelled and Developed Trial Design datasets (TA TE TV TS TI) for Several Studies based on the Analysis Plan. • Strong ability to write SQL queries using PROC SQL. Expertise at Joins set operators to combine tables horizontally and vertically creating Macro variables subqueries Complex Queries